Actively Recruiting
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
Led by Chinese University of Hong Kong · Updated on 2023-04-12
10
Participants Needed
1
Research Sites
312 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a prospective observational pilot study on pregnant women who are diagnosed to have Bart's hydrops fetalis syndrome (BHFS) affected fetuses and opt for continuation of pregnancy will be invited to consider undergoing in-utero hematopoietic stem cell transplantation under a research protocol, aiming to determine whether in-utero hematopoietic stem cell transplantation (HSCT) for fetuses with confirmed BHFS at the time of in-utero transfusion (IUT) of red blood cells could be feasible in Hong Kong. The participants will undergo bone marrow or peripheral blood stem cells harvest and an IUT combined with maternal stem cells.
CONDITIONS
Official Title
In-utero Hematopoietic Stem Cell Transplantation for the Treatment of Fetuses With Bart's Hydrops Fetalis Syndrome
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Pregnancy before 26 weeks and 0 day of gestational age with a diagnosis of BHFS confirmed by chorionic villus sampling, amniocentesis or cordocentesis
- Parents have elected to pursue in-utero transfusion and are willing to continue it throughout the pregnancy
You will not qualify if you...
- Fetuses with a second major anatomic anomaly unrelated to thalassemia that causes significant health risks
- Fetuses with other genetic or chromosomal abnormalities causing significant health risks
- Echocardiogram or ultrasound findings indicating high risk of fetal death after intervention
- Fetuses diagnosed with in-utero death before intervention
- Maternal age under 18 years, mental handicap, or severe illness
- Maternal health issues preventing stem cell harvest or fetal intervention, including bleeding disorders, cardiac disease, mirror syndrome, symptomatic anemia, preterm premature rupture of membranes, or active preterm labor
- Inability to understand English or Chinese to give consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
The Chinese University of Hong Kong
Shatin, Hong Kong
Actively Recruiting
Research Team
T
Tak Yeung LEUNG, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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